FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
VASOVIEW DUPLEX IMAGING SYSTEM
K Number: K861237
·
Decision Jul 14, 1986
Classifications
1
FEI Numbers
388
Registration Numbers
389
Same Product Code
407
Applicant Total
18
Review Days
103
Basic Information
- Device Name
- VASOVIEW DUPLEX IMAGING SYSTEM
- K Number
- K861237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- SONICAID, INC.
- Date Received
- April 2, 1986
- Decision Date
- July 14, 1986
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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Other Clearances by SONICAID, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K873673 | BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL | Feb 26, 1988 | Substantially Equivalent |
| K872074 | 5 MHZ TRANSDUCER | Aug 25, 1987 | Substantially Equivalent |
| K863803 | VASOPULSE(TM)/MODEL 5000 | May 6, 1987 | Substantially Equivalent |
| K862720 | VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES | Nov 17, 1986 | Substantially Equivalent |
| K851102 | VASOSCREEN IMPEDANCE PLETHYSMOGRAPH | May 16, 1985 | Substantially Equivalent |
| K833902 | VASOSCAN | Jan 27, 1984 | Substantially Equivalent |
| K832374 | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH | Dec 1, 1983 | Substantially Equivalent |
| K833488 | SONICOMP | Nov 28, 1983 | Substantially Equivalent |
| K833227 | SONICAID MODEL D206E AIR EMBOLI-DETECT | Oct 27, 1983 | Substantially Equivalent |
| K831371 | MODEL FM5 | Jun 30, 1983 | Substantially Equivalent |